Articles in this Issue
Sulaf Assi
Counterfeit medicines represent a global public health problem which
accounts for 10% of the world market including 50% in some countries.
Medicine counterfeiting can occur to any class of medicines, any
type of formulation and can be encountered anywhere in the world.
Consequently, rapid methods are needed to identify counterfeit medicines
at their site of origin. Handheld spectroscopic techniques offer
this advantage.
Mirlinda Biba, PhD, Jinchu Liu
Preparative supercritical fluid chromatography (SFC) has been adopted
as the technique of choice for the small scale preparative purification
of chiral compounds and it is now widely used in the pharmaceutical
industry. The benefits of preparative chiral SFC purifications, including
savings in cycle time and cost have now been fully realized.
Xiang Kou, Xiaoping Cao
The dry powder inhaler (DPI) device is paramount to the success of
a DPI product. It is the vehicle the formulation is delivered through
for local or systemic effect via pulmonary the route. The successful
delivery of drugs into the deep lung depends on the integration
between device performance and powder formulations. The
combination of the device and the formulation needs to demonstrate
safety, efficacy, bioequivalence and reliability for product approval.
Nilanjana Das, PhD
Over the last couple of decades, antibody-drug conjugates (ADCs) have
continued to evolve as a rapidly growing drug targeting technology for
the treatment of cancer. ADCs consist of a cytotoxic drug connected by
a linker to an antibody, which delivers it specifically to the target cancer
cells with abundant cell surface associated antigens.
Erin J. Ennis, Joe P. Foley
A general goal of high-performance liquid chromatography (HPLC)
is the separation of all the components of interest in increasingly
complex samples while maintaining or even reducing the analysis time.
While there are multiple approaches to address this goal, increasing
the peak capacity has certainly become an essential strategy. While
implementing that strategy, however, it is important to know the
likelihood that such an approach will lead to success.
Colin Fricker, PhD FRSB FRSPH
Water is crucial to pharmaceutical operations and the design of a water
system within manufacturing facilities must minimize the opportunity
for microbiological contamination. The type of water system used will
depend on the process, or at which stage of manufacture the API is at,
but it is paramount that the water is not detrimental to the product at
any stage. There are a number of purification techniques that can be
incorporated into the systems to reduce the microbial count, but as
important is the regular testing regime of the water, to ensure the results
are both accurate and reliable.
A few companies have developed rapid methods for monitoring
pharmaceutical grade water and are currently being evaluated by
early adopters or beta test sites within the industry. The technology is
based on real-time detection and enumeration of microorganisms via
intrinsic fluorescence when a laser (at a specific wavelength) excites
cellular components such as riboflavin and NADH.
Emilie Branch
Over the last few years, the complexity, size, length and globalization
of clinical trials have continued to grow - in parallel with soaring trial
costs. We know that the estimated average cost of bringing a drug to
market in the U.S. is about $2.6 billion,1 and the largest portion of drug
development cost is for human clinical trials; particularly for Phase III
trials, the most crucial and time-consuming phase.
Tim Sandle, PhD
Rapid microbiological method technologies aim to provide more
sensitive, accurate, precise, and reproducible test results when
compared with conventional, growth-based methods. Rapid methods
normally involve some form of automation and the methods often
capture data electronically.
Emmanuel Varesio, Sandra Jahn, Sandrine Cudré, Gérard Hopfgartner, Renzo Picenoni, Guenter Boehm
Pharmaceutical companies are under increasing pressure to bring products
from discovery through to market quickly and cost-effectively.
Where this isn’t possible, ‘fail early, fail cheap’ have become industry
watchwords in a sector where commercial drivers dictate that
investment is focused where products can be most readily developed.
Qing Zhou, PhD, Marjorie Shapiro, PhD
Since the development of anti-diphtheria antitoxins in the 19th
century, researchers and physicians have investigated antibodies
due to their remarkable characteristics and great potential for clinical
applications.
The biggest advice
we can give to be prepared is to look at the challenge holistically –
and not just as a packaging problem of putting serial numbers on
bottles. Much of the industry is viewing serialization as a packaging
line problem, when in fact, that’s only one piece of the challenge.